Medcura, Inc.

?? Insightful perspectives by Jun S. Kim, MD on Spine Surgery in ASCs ?? In his ORTHOWORLD Inc. article "Spine Surgery Makes a Lot of Sense for ASCs", Dr. Kim discusses the growing trend of performing spine surgeries in Ambulatory Surgery Centers (ASCs) and their advantages, including efficiency, cost-effectiveness, and improved patient experience. “Case migration from inpatient hospitals to outpatient settings would not be possible without recent technical advancements that make spine surgeries more feasible for ASCs,” says Dr. Kim. Among these advancements is surgical bleeding control, specifically LifeGel? — the first and only hemostatic agent to receive FDA Breakthrough Designation and recipient of Orthopedics This Week’s Best Technology in Spine Award — which is set to make spine surgeries more feasible in ASCs in the future. Read the full article here: ?? https://lnkd.in/eScteDXg #MedTech #SpineSurgery #Orthopedics #OrthopedicSurgery #Neurosurgery Disclaimer LifeGel? and its application tips are currently in development. All intended uses and/or indications for use for this medical device and its application tips have not been cleared or approved by the FDA.

The Medcura team recently sat down with Jun S. Kim an orthopedic spine surgeon at Mount Sinai West Spine Center. Dr. Kim shared his perspectives on why spine surgeons should be looking forward to LifeGel, a flowable hemostatic agent that is in development and has already received an FDA Breakthrough Device Designation. Hemostasis is crucial during spine surgery for visualization and reducing the risk of blood loss that could lead to complications. According to Dr. Kim, LifeGel is an important future spine surgery blood control innovation to watch because it: ? Has no-swell properties “As a fellow, I trained at NewYork-Presbyterian Hospital. I was taught to use flowable hemostatic agents judicially during pedicle screw insertion because of their inadvertent risk of extravasation into the spinal canal, swelling and causing serious complications. Dr. Lawrence Lenke’s group has published on this topic in the past. A no-swell product like LifeGel could mitigate the risk caused by swelling hemostatic agents potentially leading to a safer procedure,” Dr. Kim explains. ? Could facilitate the transition of some spinal surgeries to ambulatory surgery centers (ASCs) “In my own practice, a patient has been referred to me after experiencing neurologic complications caused by swelling flowable hemostatic agents left in the cervical spine,” Dr. Kim recalls. “We were able to remove the product in time for the patient to make a full recovery. I do have concerns about sending anterior cervical disc fusion (ACDF) patients home after having used a swelling flowable hemostatic agent. I would feel much more comfortable sending ACDF patients home after having used a no-swell product like LifeGel.” ? Is potentially more cost-efficient than other flowable hemostatic agents “In addition to reducing complications and making discharges safer, surgical facilities are always trying to cut costs where reasonable,” Dr. Kim observes. “Because LifeGel comes at a significant cost advantage compared to other flowable hemostatic agents, I see it as being a very obvious alternative.” ? Is ready to use with less waste “Current flowable hemostatic agents take 3-5 minutes to prepare. I typically have some flowable hemostatic agents prepared before my case so that I don’t have to wait when I need it. In some instances, product may be wasted if prepared and not used. If I need to use more product than was prepared before the case, I will have to wait for the 3-5 minutes during the case for it to be prepared. A ready to use product like LifeGel will streamline the case and potentially reduce unnecessary waste,” Dr. Kim explains. Click here to learn more: www.Medcurainc.com. #SpineSurgery #Orthopedics #OrthopedicSurgery #Neurosurgery Disclaimer LifeGel? and its application tips are currently in development. All intended uses and/or indications for use for this medical device and its application tips have not been cleared or approved by the FDA.

?? In the News! ?? This week, the Medcura team heads to the North American Spine Society (NASS) Annual Meeting in Chicago to accept the 2024/2025 Best Technology in Spine Award for LifeGel? Absorbable Hemostatic Gel. Hosted by Orthopedics This Week, the award recognizes “inventors, engineers and others who chase the dream of advancing spine surgery — and pay for that dream with marathon engineering sessions and more than a few sleepless nights.” “Spine surgery needs a transformational hemostatic technology,” said Medcura CEO Jim Buck. LifeGel is the first and only hemostatic agent to receive an FDA Breakthrough Device Designation. “Medcura is on a new wave of true innovation impacting hemostasis in a broad array of areas in medicine,” said Dr. Matthew Dowling. “I am very proud of the Medcura team, which continues to work towards the advancement of biomaterials science to meaningfully improve how surgeons manage human bleeding in a variety of high-value surgical scenarios.” ?? Learn more about LifeGel’s award and Medcura’s patented biopolymer technologies in this press release: https://lnkd.in/gkpY4FZ6 ------------ References LifeGel? and its application tips are currently in development. All intended uses and/or indications for use for this medical device and its application tips have not been cleared or approved by the FDA. https://lnkd.in/gmyDjww6 Arista ? AH Absorbable Hemostatic Particles, Instructions for Use,; Warnings. Davol Inc. Subsidiary of C. R. Bard, Inc., Warwick, RI; 2015, Arista-AH Gelfoam ? absorbable gelatin compressed sponge, USP, Instructions for Use; Warnings.?Pfizer, Pharmacia & Upjohn Company LLC, New York, NY; 05/2022 Gelfoam ? absorbable gelatin powder from absorbable gelatin sponge, USP, Instructions for Use; Warnings.?Pfizer, Pharmacia & Upjohn Company LLC, New York, NY; 05/2022 PerClot ? Polysaccharide Hemostatic System, Instructions for Use, Warnings. Starch Medical Inc., San Jose, CA, Uploaded 2019, PerClot-IFU Surgicel ? Powder, Absorbable Hemostatic Powder, Instructions for Use, Contraindications. Ethicon, LLC, San Lorenzo, Puerto Rico; 05/2017 Surgicel ? SNoW Absorbable Hemostatic, Instructions for Use, Contraindications; Adverse Events.?Ethicon, LLC, San Lorenzo, Puerto Rico; 05/2013 SurgifloTM Hemostatic Matrix Kit, Essential Product Information, Warnings; Precautions. Ethicon Johnson and Johnson Surgical Technologies; 2022, SURGIFLO-Hemostatic-Matrix-Brochure SurgicelTM Original/ Surgicel NU-KNIT/ Surgicel Fibrillar Absorbable Hemostats, Instructions for Use, Contraindications; Adverse Events. Ethicon, Neuchatel, Switzerland; 06/2013

???Exciting developments in the world of surgical innovation! With his impressive track record of market disruption in the biosurgery space, Medcura CEO?Jim Buck?has just the playbook for leading Medcura to a similar win. His visionary leadership, combined with a world class team, ensures all the right moves for bringing a life tech gamechanger like Medcura's LifeGel? to the market. ???Read Jim's article to learn more about our journey and the innovative strides we are making for the future of surgical bleeding control.??? #Leadership #Innovation #MedTech #SpineSurgery

Meet Kenneth Renkens, M.D., our esteemed Chief Medical Officer, internationally renowned neurosurgeon, and co-founder of the Indiana Spine Group. With 30 years of experience in the implantable surgical innovation space and involvement in 5 investigational hemostasis spine studies, Dr. Renkens has joined the Medcura team to lead clinical innovation of surgical hemostatic agents. “LifeGel is a particularly meaningful advancement in spine surgery where swelling of current flowable hemostatic agents in confined spaces has been known to cause neurological deficits, including paralysis,” says Dr. Renkens. With invaluable insights from Dr. Renkens, our team is thrilled for the future pioneering that our advanced technology has the potential to bring to spinal procedures. Medcura was recently awarded FDA’s Breakthrough Device Designation for the “no- swell” properties of its LifeGel hemostatic gel. Once approved, LifeGel will be the only absorbable hemostatic agent indicated for use in confined areas and will have the following labeling:?“Due to its no-swell properties, LifeGel can be used in surgical procedures where swelling cannot be tolerated.” To learn more about LifeGel, visit www.Medcurainc.com. #orthopedics #spinesurgery #orthopedicsurgery

LifeGel??is the first and only absorbable hemostatic agent to receive an FDA breakthrough designation for surgical procedures where swelling cannot be tolerated, an advantage that could be especially critical when used in confined anatomical spaces where these products are often used. The LifeGel? technology achieves hemostasis by mechanical means, coating the bleeding site via the process of mucoadhesion. To learn more, go to?www.medcurainc.com. #biotech #surgery #breakthrough

Medcura, Inc. has closed a private placement with aggregate gross proceeds of $22.4 million. We will use these funds to accelerate the development of our lead surgical product, LifeGel? Absorbable Hemostatic Gel, complete pre-clinical testing of the product, and file an Investigational Device Exemption for LifeGel with the U.S. FDA to support an?investigational study focused on stopping bleeding in spinal surgery. Current hemostatic agents swell and can cause neurological issues, including paralysis, when used in confined spaces routinely addressed in spinal surgery. ? Medcura’s Chief Executive Officer Jim Buck stated, “We remain highly encouraged by the continued momentum and pace of successes around our Life? platform of innovative surgical hemostatic agents. Our new and existing investor partners understand, and are aligned with, the Company’s strategy to seismically transform the $2.8 billion worldwide biosurgery market for hemostatic agents. This funding support is timely and crucial to further advance our progress into a pivotal clinical trial and global commercialization of the platform’s lead product, LifeGel.”? #biotech #surgery #Medcura

At Medcura, our FDA designated breakthrough biopolymer technologies and LifeGel??platform are redefining hemostasis with solutions designed to address real problems — for patients, surgeons, and payers. To learn more or see it in action, visit Medcura’s new website at?www.medcurainc.com.